Kornimate/medical-research-clean huggingface dataset:
a first in human study to evaluate safety, tolerability, pharmacology of hs-10374 in healthy subjects

Conditions: Psoriasis

Summary: the purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (pk) of hs-10374 in healthy subjects.


Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects between the ages of 18-45 years 2. have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing 3. have signed the informed consent form approved by the irb exclusion criteria: 1. have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, aids and syphilis 2. have a history of or current allergic disease 3. have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse 4. smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine 5. clinically significant abnormal physical examination, vital signs, clinical laboratory values, ecgs or imaging tests 6. pregnant or breastfeeding female subjects 7. have received hormone-based contraceptives, drugs that prolong the qt interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period
the effect of orthopedic face mask use on head posture and pharyngeal airway

Conditions: Class III Malocclusion; Hyoid Bone

Summary: the aim of this study was to evaluate the changes in head posture, position of the hyoid bone, pharyngeal airway and cervical posture after the use of petit type face mask in patients with skeletal class iii malocclusion (anb angle \< 0) with ongoing growth. no other study was found in the literature in which head posture, cervical posture, and hyoid bone position were evaluated after the use of a face mask and compared with a control group consisting of patients of the same age group and the same malocclusion.

all radiographic assessments, including cephalometric, pharyngeal airway and craniocervical measurements were performed by the same researcher and she was blind to all the treatment details, orthodontic records, and information of the subjects to prevent bias. lateral cephalometric radiographs were taken digitally with an x-ray unit (op300; instrumentarium dental, tuusula, finland) according to the manufacturer and same technician. subjects were positioned at the natural head position, teeth in centric occlusion, and lightly closed lips for lateral cephalometric radiographs. skeletal development of individuals was evaluated using cervical vertebra maturation method (ref: bacetti t., an improved version of the cervical vertebral maturation (cvm) method for the assessment of mandibular growth. angle orthod.). the skeletal development of individuals was evaluated using the cervical vertebra maturation method and it was determined that all patients were in the prepubertal stage (cs1-cs3). (ref: cevidanes l., comparison of two protocols for maxillary protraction: bone anchors versus face mask with rapid maxillary expansion. angle orthod.)

Eligibility criteria:
inclusion criteria: * for the study group it is as follows: 1. patients with skeletal class iii association (anb \< 0°) 2. maxillary insufficiency patients 3. patients with ongoing growth development 4. patients who have used a 'petit type face mask' for anterior positioning of the maxilla * for the control group it is as follows: 1. patients with skeletal class iii association (anb \< 0°) 2. maxillary insufficiency patients 3. patients with ongoing growth development 4. patients who have not had any orthodontic treatment exclusion criteria: 1. patients with a congenital anomaly or a craniofacial deformity 2. patients who have undergone orthodontic treatment 3. patients with tooth extraction or tooth loss 4. patients with a history of trauma 5. patients who have completed growth development (patients with ru on wrist film)

Keywords: class iii malocclusion craniocervical posture hyoid bone position pharyngeal airway
a safety and tolerability study of valaciclovir oral suspension in infants and children

Conditions: Herpes Simplex

Summary: limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. the marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. an extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.


Eligibility criteria:
inclusion criteria: * subjects who have a current herpes virus infection. * have neonatally acquired herpes at risk of potential recurrence. * immunocompromised or cancer patients at risk for development of a herpes virus infection. exclusion criteria: * hypersensitivity to antiherpetic medications. * impaired hepatic or renal function. * show presence of other serious or unstable underlying disease.

Keywords: pharmacokinetics herpes varicella herpes labialis epstein-barr virus
safety and tolerability of nova63035 "corticosteroid" in patients with diabetic macular edema secondary to diabetic retinopathy

Conditions: Diabetic Macular Edema

Summary: evaluation of safety and tolerability of a single injection of nova63035 "corticosteroid" administered at one of four doses in patients with diabetic macular edema (dme) secondary to diabetic retinopathy


Eligibility criteria:
inclusion criteria: * m \& f 18 years and older * diagnosed with diabetes mellitus and presenting diabetic retinopathy exclusion criteria: * monocular * history of current ocular hypertension or glaucoma in either eye defined * any significant ocular disease (other than diabetic retinopathy)

Keywords: diabetic macular edema diabetes diabetic retinopathy
neovascularization induced by mechanical barrier disruption and systemic erythropoietin in patients with cerebral perfusion deficits

Conditions: Angiogenesis; Ischemic Stroke

Summary: neovascularization induced by mechanical barrier disruption and systemic erythropoietin in patients with cerebral perfusion deficits (nimbus trial)


Eligibility criteria:
inclusion criteria: * age 20\~85 * acute period (ischemic stroke confirmation on dwi or tia within 14 days after symptom onset) * below 20 point of initial nihss score within 14 days after stroke onset and enrolment. * confirmation of atherosclerotic or steno-occlusive stroke mechanism (proximal cerebral arteries) on cta or mra . * at least hemodynamically, perfusion status of a candidate is stage ii or iii (decrease of regional cerebral blood flow on cbf map), moyamoya disease * if female then not of childbearing potential * informed consent exclusion criteria: * primary intracerebral haemorrhage (ich), or parenchymal haemorrhagic transformation of infarction (type phi or phii as defined in ecass), subarachnoid haemorrhage (sah), arterio-venous malformation (avm), cerebral aneurysm, or cerebral neoplasm * treated with a thrombolytic \ 24 hours and excluded ich then eligible) * score \>=1 on the nihss item 1a * pre-stroke mrs score \<2 * uncontrolled hypertension(irregularity systollic bp \> 150mmhg * previous treatment with erythropoietin * at screening: hemoglobin \>14 g/dl, prolonged pt or ptt, serum cr \>2.0 ,mg/dl, bun \>40, thrombocytopenia or neutropenia as defined by the lower limit of normal for the platelet count or white blood cell count, respectively (absolute neutrophil count of \> 1800/mm3 required for participation), or \> 2 times of normal on liver function tests (sgot, sgpt, total bilirubin)
nedaplatin in treatment for nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: to evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

this is a prospective, phase ii clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. this is a multicenter study. all patients will be enrolled in endemic area. all patients will receive radical intense modulate radiation therapy (imrt). the primary endpoint is objective response rate (orr).

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including who ii or iii * original clinical staged as iii-iva (except t3-4n0) according to the 8th edition american joint committee on cancer staging system * no evidence of distant metastasis (m0) * age between 18-65 * wbc≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l * with normal liver function test (tbil、alt、ast ≤ 2.5×uln) * with normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min) * satisfactory performance status: karnofsky scale (kps) \> 70 * patients must give signed informed consent exclusion criteria: * treatment with palliative intent * the primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes) * prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer * history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes * history of previous radiotherapy * pregnancy or lactation * any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.

Keywords: induction chemotherapy nedaplatin concurrent chemoradiotherapy nasopharyngeal carcinoma
cerebral blood flow regulation and concussions

Conditions: Brain Concussion; Post-Concussion Syndrome

Summary: the purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. for those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.

Eligibility criteria:
inclusion criteria: * student athletes actively participating in collegiate sports. subjects should be wiling to provide informed consent for participation in the study. exclusion criteria: * participants who are unable to play as a result of injury. presence of irregular heart beat.
invasive group b streptococcus disease burden and its antimicrobial resistance in malaysia among non-pregnant adults.

Conditions: Invasive Infection; Diabetic Foot; Immunocompromised Patients; Group B Streptococcal Infections

Summary: group b streptococcus (gbs) infection is a potential aetiology of meningitis and septicemia in neonates, pregnant women and non-pregnant adults. because the gbs disease burden is unknown in malaysia, it is unlikely to receive much attention. this study aims to determine the prevalence of group b streptococcus isolated from non-pregnant adults, the incidence, case-fatality ratio, antimicrobial susceptibility patterns, serotyping, genotyping and detection of the gbs virulence and pili genes from six major hospitals in peninsular malaysia.

this multicentre, prospective, observational study will be conducted in six major tertiary hospitals in malaysia among non-pregnant adults. at the same time, a retrospective study will be conducted on the selected hospitals to determine gbs strains and data. gbs isolates will be subjected to phenotyping, serotyping using multiplex pcr, antimicrobial susceptibility testing and detection of gbs virulence and pilus genes. seven housekeeping genes will be sequenced internally to perform multi-locus sequence typing (mlst). findings from the study will contribute to improving clinical practice to diagnose and prevent gbs disease on time. the prudent use of antibiotics will be encouraged by monitoring antimicrobial resistance.

Eligibility criteria:
inclusion criteria: * non-pregnant adult patients * patients with group b streptococcus infection * the clinical samples isolated from sterile sites (blood, cerebrospinal fluid, internal tissue, pus aspirate, peritoneal dialysis fluid, bone biopsy, skin biopsy and bone marrow). exclusion criteria: * repeated group b streptococcus that is isolated from the same patients in the same admission * non-sterile site isolates (urine, vaginal swab)
family-based interoceptive exposure for avoidant restrictive food intake disorder

Conditions: Avoidant Restrictive Food Intake Disorder

Summary: this project aims to establish the feasibility and acceptability of a comprehensive mind and body intervention; specifically a mindfulness-based interoceptive exposure (mbie) for families of youth diagnosed with avoidant/restrictive food intake disorder (arfid). this project will: (1) explore the feasibility of recruitment, retention, and data collection procedures with youth with arfid at end of treatment, (2) establish the acceptability and adherence of the mbie intervention, and (3) evaluate the number of mbie sessions required to observe changes in the number of foods avoided and mindfulness skills.

a total of 57 individuals with arfid ages 12-18 will be enrolled to outpatient mindfulness-based interoceptive exposure (mbie). mbie targets increasing psychological flexibility and acceptance by decreasing avoidance and attempts to control distressing or undesired internal experiences, and includes psychoeducation, targeted mindfulness practice, in vivo exposures, and counter-conditioning. mbie will be administered in 20 sessions. interview, self-report, anthropometrics, laboratory feeding, and behavioral task data will be used to characterize the sample to their response to treatment over time. follow-up assessments will be completed at session 5, 10, 15, and 20. the final assessment will take place 3 months after treatment ends. total participation will last 9 months.

Eligibility criteria:
inclusion criteria: patient: * aged 12-18 * speaks english * permission from pediatrician or equivalent to receive outpatient care, including that the patient does not meet criteria for hospitalization based on the american psychiatric association guidelines * diagnosis of avoidant restrictive food intake disorder, as assessed by the eda-5 parent: * has a child aged 12-18 with a diagnosis of arfid * speaks english exclusion criteria: * comorbid psychotic or bipolar disorder * psychiatric medication initiated or with a dosage change in the two weeks prior to baseline testing * active suicidal ideation * major medical condition (e.g., diabetes mellitus, pregnancy) * current substance dependence, as evidenced by tolerance and withdrawal * evidence of anatomical findings by imaging (e.g., swallow study) that would prevent safe consumption of the shake or those with a percutaneous endoscopic gastrostomy or other similar feeding tube insertion * children with visual or physical limitations that would preclude watching a screen and using a finger to respond with mouse clicks (e.g., blindness, epilepsy if exposure to flashing lights at certain intensities or to certain visual patterns can trigger seizures).

Keywords: avoidant restrictive food intake disorder eating disorder eating disorder treatment family-based therapy exposure therapy mindfulness
the effect of use of kahoot in pediatric emergency nursing course on students' course success and motivation levels

Conditions: Child, Only; Nurse's Role

Summary: with the characteristics of the new generation and the innovations brought by the age, it has become inevitable to use new educational, instructive and entertaining methods in nursing education. considering the problems experienced by nursing students with traditional education, the use of kahoot will be a remarkable result in the literature. the gamification process with kahoot encourages thinking skills in situations where the subject is sensitive and challenging, ensuring better retention of information and improving internal motivation. therefore, in order to make learning efficient and to ensure the active participation of students, it should be processed using different interactive methods in nursing education. pediatric emergency nursing course is a content-intensive and rich course that blends emergency and pediatric nursing, containing information on child health and development in addition to the learning outcomes of the emergency nursing course. this study was carried out within the scope of the pediatric emergency nursing course; it is thought that it will enable students to repeat the basic concepts of the course, master the terminology, and provide a supportive learning environment for pediatric emergency nursing, which is a difficult field for students, and will contribute to nursing education and nursing literature.

this study was planned as a randomized controlled study to determine the effect of using kahoot in the pediatric emergency nursing course on students' course success and motivation levels.

Eligibility criteria:
inclusion criteria: * those over 18 years of age, * third year nursing students, * taking the pediatric emergency nursing course for the first time, * those who have not experienced kahoot before, * nursing students who volunteer to participate in the research will be included in the research. exclusion criteria: * those who do not volunteer to participate in the research
cost-effectivness of robot-assisted surgery compared to open surgery for partial nephrectomy in context of renal tumor

Conditions: Renal Tumor

Summary: this study aim to analyze cost-effectiveness of robot-assisted surgery compared to open surgery for partial nephrectomy in the context of renal tumor. a total of 400 patients were recruited in two centers in france corresponding to reims(n=200) and nancy hospital center (n=200). patients recruited in reims are corresponding to open surgery strategy, while patients of nancy center are corresponding to robot-assisted surgery. costs analyzed included cost of intervention, hospital stay and complications. effectiveness measure is corresponding to the rate of patients without acute complication at one year.

the main objective of this study is to analyze cost-effectiveness of robot-assisted surgery compared to open surgery in the context of partial nephrectomy for renal tumor. many studies demonstrated a better post-operative outcome with robot-assisted surgery mainly in terms of lower rate of complications. results in terms of oncologic outcomes were equivalent. however, no study in france has analyzed the economic incentives of implementing robot-assisted surgery in the context of partial nephrectomy. it is very likely that the higher cost of robot-assisted surgery could be offset by a lower cost of post-operatives complications. the secondary purpose of this study is to analyze difference between robot-assisted and open surgery procedures in terms of operative time, hospital stay duration and rate of minor complications. the study is based on a retrospective cohort of 400 patients. half of patients (n=200) were recruited in nancy hospital center and are corresponding to the robot-assisted surgery procedure. the other half is corresponding to open surgery arm and where recruited in reims hospital center. inclusion criteria refer concerns patients over 18 years that were operated for minor renal tumor in nancy and reims hospital center. patients operated for total nephrectomy were excluded from the analysis. data collected refers to the cost and effectiveness of the two compared procedures. cost data are issued from hospital records and included the cost of hospital stay, surgical intervention and potential complications. data related to effectiveness are obtained from patients medical records. cost-effectiveness analysis will be conducted to estimate the cost per one averted case of post-operative complication at one year. this consists on calculating the incremental cost-effectiveness ratio (icer). sensitivity analysis will be also conducted in order to estimate de confidence interval for the icer.

Eligibility criteria:
inclusion criteria: * patients undergoing partial nephrectomy surgery for renal tumor * patients that gave informed consent for participating to the study exclusion criteria: * patients undergoing partial nephrectomy surgery for other indication * patients that refused participation to the study * patients with horseshoe kidney * patients undergoing total nephrectomy for renal tumor

Keywords: kidney cancer robot-assisted surgery cost-effectiveness
metachronous acquired contralateral cryptorchidism in patients with a history of unilateral cryptorchidism.

Conditions: Cryptorchidism

Summary: the present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.


Eligibility criteria:
inclusion criteria: * patients aged 13 years or older, previously operated on for cryptorchidism. exclusion criteria: * diagnosis of endocrine disease or any polymalformative syndrome. * synchronous bilateral cryptorchidism.

Keywords: cryptorchidism
stroke and rehabilitation in north of norway and central denmark

Conditions: Stroke, Acute

Summary: post-stroke prospective multicenter cohort study. the objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. the inclusion was of consecutive acute stroke patients with icd10 diagnosis i.63 and i.61 from a regional part of northern norway and jylland denmark. all were referred to stroke units. at baseline national stroke registry data were collected in each country. a questionnaire package was mailed to the participants 3- and 12-months post stroke. telephone interviews at 3 months post stroke added information on functioning and rehabilitation.

post-stroke prospective multicenter cohort study. the objectives of the study was to compare functioning and health related quality of life in the two study regions, in relation to known predictors and to differences in organization of treatment- and rehabilitation. the inclusion was of consecutive acute stroke patients with icd10 diagnosis i.63 and i.61 from a regional part of northern norway and jylland denmark. all were referred to stroke units. at baseline national stroke registry data were collected in each country. telephone interviews at 3 months post stroke added information on functioning and rehabilitation. a questionnaire package was mailed to the participants 3- and 12-months post stroke. these included validated questionnaires like qolibri-os, hads, ss-qol and eq5d. validity studies on qolibri-os and ss-qol has been published, along with several other papers. synne garder pedersen and guri heiberg have finished their phds.

Eligibility criteria:
* clinical diagnosis acute ischemic or hemmorhagic stroke * inclusion period mars 2014 to january 2016 * hospitalised in stroke units * living in a defined geographic area in north of norway or in central denmark

Keywords: stroke observational study rehabilitation health related quality of life